JPRN-UMIN000028309已完成未知
A multicenter phase II study of S-1+ramucirumab as first line treatment in elderly patients with advanced/recurrent gastric cancer(KSCC1701) - A multicenter phase II study of S-1+ramucirumab as first line treatment in elderly patients with advanced/recurrent gastric cancer(KSCC1701)
Kyushu Study group of Clinical Cancer0 个研究点目标入组 48 人开始时间: 2017年7月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 70years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Patients who have severe drug hypersensitivity. 2)Patients who have undergone major surgery up to 28 days prior to enrollment or in whom a central venous access device has been placed up to 7 days prior to the initial treatment. Patients who are scheduled to undergo major surgery during the study period. Patients with a severe hemorrhagic disorder within 12 weeks of enrollment. 3)Patients who have had a gastrointestinal perforation and/or fistula up to 6 months prior to enrollment. 4)Patients with a serious or non-healing wound up to 28 days prior to enrollment. 5)Patients who have had deep vein thrombosis, pulmonary embolism, or some other major form of thromboembolism up to 3 months prior to enrollment. 6)The patient has experienced any arterial thromboembolic events, within 6 months prior to first protocol therapy. 7)Patients receiving chronic administration of a non-steroidal antiinflammatory drug or some other antiplatelet drug. 8)Patients with an active infection. 9)Patients with hypertension (>160 mmHg systolic or > 100 mmHg diastolic for >4 weeks) that cannot be adequately controlled with 2 antihypertensives. 10)Patients with diabetes mellitus that cannot be controlled adequately with medication. 11)Patients with heart disease that may pose a problem. 12)Patients with severe pulmonary disease. 13)Patients with a psychiatric disorder. 14)Patients with active gastrointestinal tract bleeding requiring repeated transfusions. 15)Patients receiving phenytoin, warfarin potassium, or flucytosine. 16)Patients with diarrhea (Grade 2 or worse). 17)Patients with active multiple cancers. 18)Men who wish to conceive with a partner. 19)Patients with hepatic cirrhosis or active hepatitis. 20)Patients with cirrhosis, with a history of hepatic encephalopathy, or with clinically significant ascites. 21)Other patients whom a lead investigator or the patient's primary physician deems are not appropriate for this study.
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